The Ministry of Health is the governing body in New Zealand in charge of managing and developing the country's health system. The ministry funds, monitors, and regulates the performance of the health sector, ensuring all legislative requirements are met. Within the Ministry of Health, the New Zealand Medicine and Medical Devices Safety Authority (MEDSAFE) is the unit responsible for regulating therapeutic products in the country.
By administering the Medicines Act 1981 and Regulations 1984, Medsafe regulates medicine, medical devices, and other related products, such as food or cosmetics with therapeutic uses. The authority is thus responsible for pre-market approval and post-market surveillance, such as monitoring adverse reactions and handling complaints, as well as auditing and licensing medical manufacturers.
A list of Medsafe regulations can be found here on our website.
我们的专家将详细解读2023年韩国食品药品安全部(MFDS)指导文件草案更新下韩国医疗器械注册监管要求、分类标准、韩国良好生产规范(KGMP)等相关要求,并将依据多年韩国本地注册经验提供注册案例分享。此外,您还将了解到制造商在面对MFDS监管时需要关注的核心要点,相关研讨会内容包括:
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